Pharmaceutical Regulatory Affairs Specialist

5 days ago

Hyderabad Secunderabad Telangana, India beBeeCompliance Full time ₹ 1,04,000 - ₹ 1,30,878

Role Overview:

The Regulatory Compliance Change Assessor plays a critical role in ensuring the compliance of change records within our organization.

Key Responsibilities:

  • Reviews change records to evaluate the impact of changes on reportability and product restrictions for products in scope.
  • Defines and documents reporting and product distribution restriction requirements for changes within our change control management system.
  • Liaises with other functions, including Process Development, Operations, Quality, and Supply Chain, to ensure alignment of regulatory strategies.

What We're Looking For:

We're seeking an individual with a strong background in regulatory affairs and excellent communication skills. The ideal candidate will have experience in manufacturing, quality assurance/quality control, or clinical trials in the pharmaceutical or biotechnology industry.

Requirements:

  • Masters degree OR
  • Bachelors degree and 2 years of relevant experience in the pharmaceutical or biotechnology industry OR
  • Associates degree and 6 years of relevant experience in the pharmaceutical or biotechnology industry OR
  • Diploma and 8 years of relevant experience in the pharmaceutical or biotechnology industry

Preferred Qualifications:

  • Degree in a Life Science discipline
  • Regulatory CMC specific knowledge and experience
  • Understanding and application of principles, concepts, theories, and standards of scientific/technical fields
  • Experience in manufacture, testing (QC/QA or clinical), or distribution in the pharmaceutical or biotech industry

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